← Product Code [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN) · K943149

# ACCESS RED BLOOD CELL FOLATE ASSAY (K943149)

_Beckman Coulter, Inc. · CGN · Aug 26, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K943149

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN.md)
- **Decision Date:** Aug 26, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1295
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K943149](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K943149)

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